Senior Quality Engineer NPD

Johnson & Johnson • Irvine, CA

6d • Onsite

About The Position

The Senior Quality Engineer plans, coordinates, and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product. This role is involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations, and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, this role assists to develop quality-engineered systems and products, and support qualification and validation activities. The Senior Quality Engineer will be considered a subject matter expert (SME) on Quality matters and relevant Quality tools, and will work on complex problems and projects. This role will show leadership in driving programs/projects and innovating compliant approaches and solutions to problems. The Senior Quality Engineer will share technical expertise with others and develop other engineers. Responsibilities may involve collaborating with other members of the Design Team, contributing to activities including risk management document development, creation and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.

Requirements

• Bachelor’s degree, required; preferably in engineering and/or scientific discipline Or a minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
• Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Ability to develop and implement Quality standards
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
• Lean manufacturing experience
• Knowledge of Quality and operations systems and processes, including GMP
• Working knowledge of CAD software (Solidworks, AutoCAD)
• Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.

Nice To Haves

• Working knowledge of SolidWorks, other CAD based programs (i.e.. basic dimensioning, tolerance stack analysis) is a plus.
• Experience with Minitab, R and other statistical software is a plus.

Responsibilities

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
• Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Performs other duties assigned as needed.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior